Pericardial Devices, Systems and Methods for Occluding an Atrial Appendage

ABSTRACT

Disclosed are devices for pericardial access to the heart, including direct access to the left atrium. In certain embodiments, the device may comprise a device and/or an atrial appendage (AA) portal having a configuration such that the distal end of the device and/or the portal can access an atrial appendage while the proximal end of the device and/or portal can extend to outside of the subject. The devices and methods may also include a pericardial portal for emplacement of the device and/or the AA portal. Also, methods for using such devices and/or AA portals and pericardial portals to perform surgery on the heart, and systems (e.g., kits) comprising these devices and/or portals in combination with other therapeutic devices are disclosed.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/454,571, filed Aug. 7, 2014, (U.S. Pat. No. 9,463,024), which is acontinuation of U.S. patent application Ser. No. 13/151,403 filed Jun.2, 2011, (U.S. Pat. No. 8,814,778), which claims the benefit of priorityto U.S. Provisional Application No. 61/351,043 filed Jun. 3, 2010. U.S.patent application Ser. No. 13/151,403 is also a continuation-in-part ofU.S. patent application Ser. No. 12/456,855 filed Jun. 23, 2009(abandoned), which claims the benefit of priority to U.S. ProvisionalApplication Nos. 61/135,260 filed Jul. 19, 2008 and 61/191,062 filedSep. 6, 2008. The entire content of each of the above filings isincorporated herein by reference for all purposes.

FIELD OF THE INVENTION

The present invention relates to devices, systems and methods forpericardial access, visualization, and exclusion and/or removal of anatrial appendage.

Atrial Appendage Therapies

For patients with isolated atrial fibrillation (AF), the left atrialappendage (LAA) may be the source of embolic events, such as stroke andheart attack (Blackshear J L and Odell J A, Appendage obliteration toreduce stroke in cardiac surgical patients with atrial fibrillation,Ann. Thorac. Surg., 1996; 61:755-759). Many physicians feel thatexclusion or ligation of the LAA is indicated for patients with AF toreduce this risk. The less invasive Percutaneous Left Atrial AppendageTranscatheter Occlusion (PLAATO) device and the Watchman Device(Atritech; Plymouth, Minn.) have been designed to exclude the LAA fromcirculation and thus, reduce embolic events. The device can be placedinside the heart at the base of the left atrial appendage through adefect created in the atrial septum with a catheter in the femoral vein,a large vein in the groin. Although minimally invasive, the procedurecan be technically challenging and may leave a compromised communicationbetween the left and right atrium. Surgeons often exclude the LAA duringcardiac surgical procedures in patients with atrial fibrillation.However, for those patients with isolated atrial fibrillation who do notrequire sternotomy for cardiac surgery, a less invasive surgicalexclusion is desirable.

Methods have been described which utilize mini-thoracotomy orthoracoscopic access to surgically exclude or remove the LAA duringprocedures to treat atrial fibrillation. Techniques described includeremoval or exclusion of the LAA from inside the left atrium while theheart is arrested during cardiopulmonary bypass (Rodriguez E, Cook R C,Chu M W A, and Chitwood W R, Jr., Minimally invasive bi-atrial cryomazeoperation for atrial fibrillation, Operative Techniques in Thorac andCardiovasc Surg., 2009; 14:208-223), and amputation of the LAA while theheart is beating using an endoscopic stapler (Edgerton J R., Totalthoracoscopic ablation of atrial fibrillation using the Dallas lesionset, partial autonomic denervation, and left atrial appendectomy,Operative Techniques in Thorac. and Cardiovasc Surg., 2009; 14:224-242).New devices have been developed to enable less invasive LAA exclusion(e.g., the Cosgrove-Gillinov Left Atrial Appendage Occlusion System,Atricure, West Chester, Ohio; and the Cardioblate Closure Left AtrialAppendage Occlusion Device, Medtronic, Minneapolis, Minn.). Clinicalinvestigation is underway for these devices.

Direct access and visualization of the LAA has required painfulincisions in the chest which often delay recovery. Access to the LAAwith pericardial visualization is now possible via a subxyphoid ortransdiaphragmatic approach. The pericardium is a tough, fibrous sac,filled with fluid, and that surrounds the heart. This sac allows freemovement of the heart while it is beating. The sac can enlarge over timeif too much pericardial fluid is generated or if the heart enlarges. Thesac can also become inflamed and attach to the surface of the heart dueto surgery, infection, or malignancy.

Pericardioscopy, or paracardioscopy, relates to accessing the heartwithin the pericardial sac using endoscopic techniques. The developmentof pericardioscopy (U.S. patent application Ser. No. 12/456,855incorporated herein by reference) has enabled similar “keyhole”procedures for diseases of the chest but without the use of robotics.Pericardioscopy may use a device which is positioned via a surgicaldefect (opening) in the diaphragm into the pericardial space.Alternatively, access to, and visualization within, the pericardiumusing a device through an incisions beneath the xyphoid is an acceptableprocedure. The device can create a temporary space within thepericardium, between the heart and the pericardial sac, wherevisualization, manipulation, and procedures can be performed on theheart surface.

For example, pericardioscopy may be used to treat atrial fibrillation(AF) and atrial flutter. In this procedure, a cannula may be used toaccess the outside of the heart via the pericardial sac. Then, anablation device may be juxtaposed against the epicardial surface atspecific locations to thereby scar (i.e., ablate) the heart tissue insuch a manner so as to short-circuit any electrical activity(fibrillations) occurring in the heart. Pericardioscopy provides thedirect visualization and the direct access to the epicardial surface ofthe heart vital to the totally endoscopic treatment of AF (Kiser et al.,Innovations 2008; 3:117).

While methods and devices that use pericardial procedures are availablefor treatment of atrial fibrillation (AF), there is a need to developdevices and procedures such that pericardial or subxyphoid access to theheart can be used in other procedures. There is also a need to developdevices and procedures such that other organs in the thoracic cavity canbe accessed and treated endoscopically. Thus, the present inventioncomprises pericardial-based devices, systems or methods for ligation ofan atrial appendage, including the LAA.

SUMMARY

Embodiments of the present invention comprise endoscopic devices,systems and methods for occluding an atrial appendage via pericardialaccess to the heart. The method may be embodied in a variety of ways.

In certain embodiments, the invention comprises a device for performinga surgical procedure on an atrial appendage, wherein at least a portionof the device is configured for insertion of at least a portion of theatrial appendage into a portion of the device and configured to excludeand/or remove an atrial appendage from an atrium to which the appendageis attached.

Yet other embodiments of the present invention comprise methods toaccess an atrial appendage of a heart in a subject via a pericardialapproach so as to perform a surgical procedure upon the atrialappendage. The method may comprise the steps of inserting a portion ofportal comprising a device for performing a surgical procedure on anatrial appendage into the pericardium of the subject, wherein at least aportion of the device is configured for insertion of at least a portionof the atrial appendage into a portion of the device and configured toexclude and/or remove an atrial appendage from an atrium to which theappendage is attached, and wherein the portal comprises a proximal endhaving an opening and a distal end having an opening and a lumenconnecting the proximal and distal openings; manipulating the proximalend of the portal to position the distal opening of the portal at ornear the surface of the atrium; and inserting at least a portion of theatrial appendage into the device or the portion of the device.

The present invention also comprises systems for occluding or removingan atrial appendage. For example, the system may comprise a device fortying off an atrial appendage, and an AA portal and/or a pericardialportal. In an embodiment, the invention comprises a system for tying offan atrial appendage comprising a device for performing a surgicalprocedure on an atrial appendage via a pericardial approach, wherein atleast a portion of the device is configured for insertion of at least aportion of the atrial appendage into a portion of the device andconfigured to exclude and/or remove an atrial appendage from an atriumto which the appendage is attached and a portal for positioning thedevice in close proximity to the atrial appendage.

The present invention may be better understood by reference to thefollowing non-limiting description.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates insertion of an atrial appendage (AA) portal or outerpericardial portal via a transdiaphragmatic subxyphoid approach with theportal and endoscope passing from external to the body, through theincision and into the pericardial sac towards the left atrial appendage(LAA), in accordance with an embodiment of the present invention.

FIG. 2 illustrates an AA portal and associated endoscope in accordancewith an embodiment of the present invention, showing the LAA within thedistal opening of the AA portal and visualized with the endoscope.

FIG. 3, panels A-B, illustrates the exclusion of an AA with a feltreinforced lasso of suture placed at the base of the AA under directvisualization using an AA portal in accordance with an embodiment of thepresent invention. Panel A shows the suture within the AA portal andloose around the base of the LAA, panel B illustrates the felt andsuture tightened at the proper location for exclusion.

FIG. 4, panels A-C, illustrates the use of a device for tying off an AA(e.g., LAA) using a pericardial approach in accordance with anembodiment of the present invention, where panel A shows a top view ofthe felt-covered suture and two knot pushers, panel B shows the felt andsuture emplaced on the AA, panel C shows the process of the two knotpushers tightening the suture on the AA, panel D shows the suturetightened on the AA and panel E shows a perspective view of the feltcovered suture and two knot pushers within the AA portal.

FIG. 5, panels A-D, illustrates a method of deploying a device forisolation of an AA according an alternate embodiment of the presentinvention, where panel A shows an AA portal having an atrial tying bandon its distal end with two knot pullers and an endoscope disposed withinthe lumen of the AA portal, panel B shows the AA portal positioned nextto the LAA, panel C shows the LAA aspirated into the AA portal, andpanel D shows the band having been removed from the AA portal andpositioned on the LAA.

FIG. 6, panels A-B, illustrates a method of deploying a device for LAA(or RAA) exclusion and isolation in accordance with an embodiment of thepresent invention where panel A shows a curvilinear AA portal having atying band on its outer circumference in approximation to the myocardiumaround the AA and the AA within the distal opening, and panel B showsthe band removed from the distal end of the AA portal and emplacedaround the base of the AA.

FIG. 7, panels A-C, illustrate a rectangular AA portal (panels A and B)or a device (panel C) used with a pericardial portal with anincorporated controllable release and deployment mechanism of the distalAA clip occlusion device in accordance with an embodiment of the presentinvention. Panels A and C illustrate the distal clip occlusion device inthe open position; panel B illustrates the distal clip occlusion devicein the closed position.

FIG. 8, panels A-E, illustrate a rectangular distal band/clip to bepositioned at the distal end of the AA portal or a device used with apericardial portal for occlusion of the appendage in accordance with anembodiment of the present invention. Panel A illustrates a view of asingle side of the band/clip device; panel B illustrates the band/clipfrom above; panel C is another illustration of the clip/band; panel Dillustrates a view of the band/clip without associated collars; panel Eillustrates a view of the band/clip in the closed position.

FIG. 9, panels A-C, illustrate an oval AA portal (panels A-B) or adevice (panel C) used with a pericardial portal with an incorporatedcontrollable release and deployment mechanism of the distal AA clipocclusion device in accordance with an embodiment of the presentinvention. Panels A and C illustrate the distal clip occlusion device inthe open position; panel B illustrates the distal clip occlusion devicein the closed position.

FIG. 10, panels A-E, illustrate an oval distal band/clip to bepositioned at the distal end of the AA portal or a device used with apericardial portal for occlusion of the appendage in accordance with anembodiment of the present invention. Panel A illustrates a view of theband/clip device; panel B illustrates the band/clip open; panel C isanother illustration of the clip/band more open; panel D is anotherillustration of the clip/band open and with collars; panel E illustratesa view of the band/clip closed.

FIG. 11, panels A-D, illustrates clips positioned around an atrialappendage in accordance with various embodiments of the invention wherepanels A and B show an oval distal band/clip positioned around an atrialappendage where panel A shows the clip open, and panel B shows the clipclosed around the atrial appendage, and panels C and D show adiamond-shaped clip positioned around an atrial appendage where panel Cshows the clip open, and panel D shows the clip closed around the atrialappendage.

DETAILED DESCRIPTION

Embodiments of the invention comprise pericardial-based atrial appendage(AA) exclusion devices, systems and methods of use of such devices andsystems.

In various embodiments of the devices of the invention, an atrialappendage (AA) portal or a pericardial portal may be used to access theatrial appendage.

As used herein, a pericardial portal is an access member configured toprovide access to the pericardium from an incision made in a subject,and having a distal opening and a proximal opening and a lumen thatconnects the distal opening and the proximal opening. Thus, the portalis generally long enough to access the pericardium from an incision(e.g., subxyphoid) but has a circumference that is minimized so as toreduce trauma to the subject. A pericardioscopic portal is a pericardialportal that includes an endoscope.

As used herein, an atrial appendage (AA) portal is an access memberconfigured to provide access to the atrial appendage from an incisionmade in a subject, and having a distal opening and a proximal openingand a lumen that connects the distal opening and the proximal opening.Thus, like the pericardial portal, the AA portal is generally longenough to access the pericardium from an incision (e.g., subxyphoid) andhas a circumference that is minimized so as to reduce trauma to thesubject. Generally, the AA portal and the pericardial portal are similarin configuration, except that the AA portal is configured to access anatrial appendage, and so may be smaller in diameter than a pericardialportal. In some cases, the AA portal and the pericardial portal are usedtogether, such that the pericardial portal is used to access thepericardium, and the AA portal is used either singly, or inserted withinthe lumen of the pericardial portal, to access the atrial appendage. AnAA portal may also include an endoscope.

In an embodiment, the AA portal and/or the pericardial portal is acylinder. In certain embodiments, the AA portal and/or the pericardialportal is a cannula. In certain embodiments, the AA portal and/or thepericardial portal is a tube. In certain embodiments, the AA portaland/or the pericardial portal is an oval cylinder. In certainembodiments, the AA portal is a rectangular tube. Or, in certainembodiments, the device to be used in conjunction with the pericardialportal comprises an round cylinder, an oval cylinder or a rectangulartube.

As described in more detail herein, the AA portal may comprise a singleportal and/or may be used in conjunction with a second, outer cannula orportal, such as a pericardial portal. For example, in certainembodiments, the device may comprise an outer pericardial portal fordelivering the AA portal to an atrial appendage. Or, the pericardialportal may be used with a device that can occlude an atrial appendage,but that is not an atrial appendage portal.

As used herein, “distal” refers to the end of a device that is furthestfrom the operator (e.g., physician). “Proximal” refers to the end of adevice that is closest to the operator. For example, the “distal” end ofa cannula or portal is the end inserted into a patient and the“proximal” end is the end that is outside of the patient and that can bemaneuvered by a physician.

Also, as used herein, the terms “expandable” and/or“expandable/contractible” are used interchangeably to denote a materialthat can expand and/or contract from a first position to a secondposition. Such materials may be made of an elastic type material and/orhave elastic properties.

Thus, in certain embodiments, the invention comprises a device forperforming a surgical procedure on an atrial appendage, wherein at leasta portion of the device is configured for insertion of at least aportion of the atrial appendage into a portion of the device andconfigured to exclude and/or remove an atrial appendage from an atriumto which the appendage is attached. In an embodiment, the devicecomprises a portal comprising a proximal end having an opening and adistal end having an opening and a lumen connecting the proximal anddistal openings, wherein the distal end is configured for insertion ofat least a portion of the atrial appendage into a portion of the device.In an embodiment, the distal end of the device and/or the portal canaccess an atrial appendage while the proximal end of the device and/orportal can extend to outside of the subject.

In certain embodiments, and as described in more detail herein, thedistal end of the device is curvilinear such that the distal end is notparallel to the longitudinal axis of the device.

In certain embodiments and as described in more detail herein, thedevice for performing a procedure on the atrial appendage is configuredto be inserted into a pericardial portal, the pericardial portalcomprising a proximal end having an opening and a distal end having anopening and a lumen connecting the proximal and distal openings. Also,in certain embodiments the portal may comprising a cannula comprising aproximal end having an opening and a distal end having an opening and alumen connecting the proximal and distal openings. In some embodiments,the device may be used with an endoscope.

In certain embodiments, suction can be applied to create a seal betweenat least a portion of the distal opening of the device and at least partof the atrial appendage. Also, in certain embodiments the device maycomprise a soft material at the distal end.

The device for occluding the atrial appendage may, in certainembodiments comprise a tying band configured to be tied around a portionof the atrial appendage. In certain embodiments, at least a portion ofthe tying band comprises a material designed to cushion the tying band.

In other embodiments, the device for occluding the atrial appendage maycomprise an expandable and/or contractible band positioned on or nearthe distal end. In some embodiments, the device may further comprise aninflatable member positioned on the distal end. The device may also, incertain embodiments, comprise a lumen configured to inflate theinflatable member.

The inflatable member may be used to facilitate positioning of theexpandable and/or contractible band on the atrial appendage. Forexample, in certain embodiments, the expandable and/or contractible bandis positioned proximal to the inflatable member such that when theinflatable member is inflated, the band is secured on the distal end ofthe device, and when the inflatable member is deflated, the band can beurged over the deflated inflatable member so as to be released from thedistal end of the device. Alternatively, in other embodiments, theexpandable and/or contractible band is positioned substantially on topof the inflatable member, such that when the inflatable member isdeflated, the band is secured on the distal end of the device, and whenthe inflatable member is inflated, the band is pushed off the distal endof the device.

The device may comprise a contractible end that can be used to clamp theatrial appendage. For example, in certain embodiments, the distal end ofthe device is sufficiently flexible so as to be collapsed around the endof an atrial appendage.

Additionally and/or alternatively, the device may comprise a clip and/orband positioned at the distal end, and which may be positioned around anatrial appendage so as to occlude the atrial appendage from theremainder of the atrium. The clip and/or band may be shaped to have atleast two longer sides and two shorter sides such that when the clipand/or band is closed around the atrial appendage, the longer sidesflatten the appendage in a manner so as to substantially avoid plicationof the appendage. For example, in alternate embodiments, the clip orband is oval, rectangular or diamond in shape. Also in certainembodiments, the clip and/or band is releasably engaged with the distalend of the device, such that when the clip and/or band is collapsedaround an atrial appendage, the clip or band may be released from theend of the device so as to collapse around at least a portion of theatrial appendage.

In certain embodiments, the distal end of the device is shaped tocollapse around an atrial appendage without the application of force. Incertain embodiments, the device comprises a mechanism to open the distalend. For example, in certain embodiments, the mechanism to open thedistal end of the portal and/or the device comprises at least one barthat when urged distally, pushes the distal end of the portal and/or thedevice from a naturally closed configuration to an open configuration.In certain embodiments, the clip and/or band is releasably engaged withthe distal end, such that when the clip and/or band is collapsed aroundan atrial appendage, the clip or band may be released from the end ofthe device so as to collapse around at least a portion of the atrialappendage.

For each of the embodiments, of the devices, methods and systems, thedevice may be configured specifically to access either the left atrialappendage or the right atrial appendage.

Yet other embodiments of the present invention comprise methods toaccess an atrial appendage of a heart in a subject via a pericardialapproach so as to perform a surgical procedure upon the atrialappendage. The method may comprise the steps of inserting a portion ofportal comprising a device for performing a surgical procedure on anatrial appendage into the pericardium of the subject, wherein at least aportion of the device is configured for insertion of at least a portionof the atrial appendage into a portion of the device and configured toexclude and/or remove an atrial appendage from an atrium to which theappendage is attached, and wherein the portal comprises a proximal endhaving an opening and a distal end having an opening and a lumenconnecting the proximal and distal openings; manipulating the proximalend of the portal to position the distal opening of the portal at ornear the surface of the atrium; and inserting at least a portion of theatrial appendage into the device or the portion of the device.

In certain embodiments, the portal comprises an atrial appendage portalcomprising a proximal end having an opening and a distal end having anopening and a lumen connecting the proximal and distal openings, whereinthe distal end is configured for insertion of at least a portion of theatrial appendage into a portion of the device.

In certain embodiments, the method comprises inserting the device and/orthe atrial portal into an outer pericardial portal and positioning thedistal opening of the atrial appendage portal at the surface of theatrium. Also, in certain embodiments, at least a portion of the distalend of the device and/or the portal(s) is curvilinear such that thedistal opening is not parallel to the longitudinal axis of the device.The method may also comprise using an endoscope to provide an image ofbody structures present near the distal end of the portal(s). Also, incertain embodiments, the portal(s) and/or the device comprises a softmaterial surrounding the distal end of the portal and/or the device.

Also, in certain embodiments, the method further comprises applying avacuum to an inner lumen of the portal (e.g., atrial appendage portal orpericardial portal) or the device to encourage the atrial appendage intoat least a portion of the device or the portal and/or to create a sealbetween the distal opening of the device and at least part of the atrialappendage.

In certain embodiments, the method may comprise positioning a device toexclude and/or remove an atrial appendage at the distal end of theatrial appendage portal and/or the pericardial portal.

A variety of devices may be used to occlude the atrial appendage in themethods of the invention. In an embodiment, the device comprises a tyingband configured to be tied around a portion of the atrial appendage. Incertain embodiments, the tying band comprises a suture. In certainembodiments, at least a portion of the suture comprises a materialdesigned to cushion the suture. For example, the method may compriseproviding the tying band at the distal opening of the portal, using thetying band to encircle at least a portion of the atrial appendage, andtightening the tying around the atrial appendage to exclude the atrialappendage from the atrium to which the appendage is attached.

In other embodiments, the device comprises an expandable and/orcontractible band and/or clip positioned on or near the distal end ofthe device and/or the portal. For example, in an embodiment, theexpandable and/or contractible band and/or clip is removed from thedistal end of the portal and/or the device and positioned on the atrialappendage so as to encircle at least a portion of the atrial appendageand thereby exclude the atrial appendage from the atrium to which theappendage is attached. In this embodiment, an inflatable member may beused to secure the expandable and/or contractible band and/or clip onthe distal end of the portal and/or the device. For example, in anembodiment, the expandable and/or contractible band may be positionedproximal to the inflatable member, such deflating the inflatable membercan release the expandable and/or contractible band and/or clip from thedistal end of the portal and/or the device. Or, the expandable and/orcontractible band or clip can be positioned substantially on top of theinflatable member, such that inflating the inflatable member urges theexpandable and/or contractible band and/or clip from the distal end ofthe portal and/or the device.

In an embodiment, the expandable (and/or contractible) band and/or clipused in the methods of the invention is configured to close around theatrial appendage upon emplacement of the clip and/or band on the atrialappendage. In certain embodiments, the expandable and/or contractibleband and/or clip is removed from the distal end of the portal and/or thedevice and positioned on the atrial appendage so as to encircle at leasta portion of the atrial appendage to exclude the atrial appendage fromthe atrium to which the appendage is attached Additionally oralternatively, the distal end of the device and/or the portal may beconfigured to be collapsible around an atrial appendage. In someembodiments, the expandable and/or contractible band and/or clip isreleasably secured to the inner lumen of the portal and/or the device.For example, a suture may be used to releasably secure the expandableand/or contractible band and/or clip to the inner lumen of the portaland/or the device such that cutting the suture will release theexpandable and/or contractible band and/or clip from the distal end ofthe portal and/or the device.

In certain embodiments of the method, the clip and/or band may be shapedto have at least two longer sides and two shorter sides such that whenthe clip and/or band is closed around the atrial appendage, the longersides flatten the appendage in a manner so as to substantially avoidplication of the appendage. For example, the clip or band may be oval,rectangular or diamond in shape. Or, clips and/or bands of other shapesmay be used, such that when the clip and/or band is contracted, it canocclude the atrial appendage. In an embodiment, the distal end of thedevice and/or the portal is configured to be collapsible around anatrial appendage.

In some embodiments, the distal end of the portal and/or device isshaped to collapse around an atrial appendage without the application offorce. In such embodiments, the portal and/or the device may comprise amechanism to open the distal end. For example, the mechanism to open thedistal end of the portal and/or the device may comprise at least one barthat when urged distally, pushes the distal end of the portal and/or thedevice from a naturally closed configuration to an open configuration.In an embodiment, the clip and/or band is releasably engaged with thedistal end of the portal and/or the device, such that when the clipand/or band is collapsed around an atrial appendage, the clip or bandmay be released from the end of the portal and/or the device so as tocollapse around at least a portion of the atrial appendage.

For example, in an embodiment, the portal and/or the device comprises acollapsible distal end with a clip and/or band that can be positioned inthe distal end of the portal and/or the device and then allowed tocollapse around an atrial appendage and comprising the steps of: usingsuction to positioning the atrial appendage in the distal end of theportal and/or the device; collapsing the distal end of the portal and/orthe device and associated clip and/or band around the atrial appendage;and releasing the clip and/or band from the AA portal and/or the deviceso that the clip and/or band remains on the atrial appendage when theportal is removed.

The present invention also comprises systems for occluding or removingan atrial appendage. For example, the system may comprise a device fortying off an atrial appendage, and an AA portal and/or a pericardialportal. In certain embodiments the system may comprise a device forperforming a surgical procedure on an atrial appendage via a pericardialapproach, wherein at least a portion of the device is configured forinsertion of at least a portion of the atrial appendage into a portionof the device and configured to exclude and/or remove an atrialappendage from an atrium to which the appendage is attached and a portalfor positioning the device in close proximity to the atrial appendage.

In certain embodiments for the systems of the invention, at least aportion of the distal end of the AA portal and/or the pericardial portalis curvilinear such that the distal opening is not parallel to theproximal opening and the longitudinal axis of the lumen is not linear.In this way, the portal may comprise a configuration suitable to abutthe atrial surface, while being manipulated via a subxypoid entry.

Also, in certain embodiments of the systems, the AA portal is configuredto be inserted into an outer pericardial portal, where the pericardialportal comprises a proximal end having an opening and a distal endhaving an opening and a lumen connecting the proximal and distalopenings. In this way, the outer pericardial portal may be used todeliver the AA portal to the site of the atrial appendage. Also, incertain embodiments, the AA portal and/or the pericardial portal mayfurther comprise an inner cannula within the lumen of the portal, theinner cannula comprising a proximal end having an opening and a distalend having an opening and a lumen connecting the proximal and distalopenings. For example, the inner cannula may be used to deliver surgicaltools and other devices to the site of the atrial appendage. Also, incertain embodiments, either the AA portal or the outer percardioscopicportal may comprise an endoscope within at least a portion of the lumenof the portal.

The atrial and/or pericardial portal may be designed so that the distalend can be securely positioned on or near the atrial surface to allowfor surgical procedures to be performed. For example, in certainembodiments suction can be applied within the lumen of the AA portal tocreate a seal between the distal opening of the AA portal and at leastpart of the atrial appendage. Also, in certain embodiments, the AAportal and/or the pericardial portal and/or the device for use with thepericardial portal may comprise a soft material surrounding the distalopening. In an embodiment, the soft material provide a cushion to reducetrauma to the atrial surface and/or to increase sealing between thedistal end of the AA portal and the atrial surface.

The following non-limiting embodiments may apply to each of the devices,systems and methods of the invention.

In various embodiments of the devices, systems and methods of thepresent invention, the AA portal may comprise a device that is separatefrom the AA portal to exclude and/or remove an atrial appendage from anatrium to which the appendage is attached. A variety of devices suitablefor occluding and/or isolated an atrial appendage from the atrium may beused.

For example, in one embodiment, the device comprises a tying bandconfigured to be tied around a portion of the atrial appendage. In anembodiment, the tying band is a suture. In an embodiment, at least aportion of the suture comprises a material designed to cushion thesuture.

In another embodiment, the device may comprise an expandable and/orcontractible band. The band may be positioned on or near the distal endof the AA portal. Or, the band may be positioned on the distal end of adevice that is delivered to the atrial appendage via a pericardialportal.

In certain embodiments, the AA portal, pericardial portal, or the deviceused with a pericardial portal may further comprise an inflatable memberpositioned on the distal end of the portal and/or the device. Also, theportal (i.e., AA or pericardial) and/or device may further comprise alumen configured to inflate the inflatable member. In this way, anexpandable and/or contractible band may be positioned proximal to theinflatable member such that when the inflatable member is inflated, theband is secured on the distal end of the portal and/or the device, andwhen the inflatable member is deflated, the band can be urged over thedeflated inflatable member and released from the distal end of theportal and/or the device.

For example, an outer cylinder concentric with the outer diameter of thedevice used with a pericardial portal and/or an AA portal may bepositioned near the distal end of the AA portal or the device. In anembodiment, the outer cylinder has an inner diameter that is larger thanthe outer diameter of the AA portal or device, but smaller than theouter diameter of the expandable and/or contractible bands. In this way,when the outer cylinder is advanced distally, it can urge the band offof the AA portal or the device and onto the atrial appendage.

In one embodiment, the device for occluding an atrial appendage maycomprise a distal end having an opening and a lumen, wherein the distalend is configured for insertion of at least a portion of the atrialappendage into the distal opening. The device may further comprise anelement (e.g., pincers or another type of grabbing element) that is usedto pull the atrial appendage into the lumen of the device. Or, suctionmay be used to pull the atrial appendage into the device. Then, anexpandable and/or contractible band positioned on the distal end of thedevice may be removed from the distal end of the device and positionedon the atrial appendage to occlude the atrial appendage. For example, anouter cylinder concentric with the outer diameter of the device may bepositioned near the distal end of the device. In an embodiment, theouter cylinder has an inner diameter that is larger than the outerdiameter of the device, but smaller than the outer diameter of theexpandable and/or contractible bands. In this way, when the outercylinder is advanced distally, it can urge the band off of the deviceand onto the atrial appendage.

Or, the expandable and/or contractible band positioned on the distal endof the AA portal and/or the device used with a pericardial portal may bepositioned substantially on top of an inflatable member, such that whenthe inflatable member is deflated, the band is secured on the distal endof the portal, and when the inflatable member is inflated, the band ispushed off of the distal end of the portal or the device.

In certain embodiments, the distal end of the AA portal or the deviceused with a pericardial portal is sufficiently flexible so as to becollapsed around the end of an atrial appendage. Or, the distal end ofthe AA portal or the device used with a pericardial portal may besubstantially firm, so as to maintain an open configuration throughoutthe procedure.

Also, in certain embodiments, the AA portal or the device used with apericardial portal may further comprise a clip and/or band positioned atthe distal end of the portal or the device which may be positionedaround an atrial appendage so as to occlude the atrial appendage fromthe remainder of the atrium. In certain embodiments, the clip and/orband is shaped to have at least two longer sides and two shorter sidessuch that when the clip and/or band is closed around the atrialappendage, the longer sides flatten the appendage in a manner so as tosubstantially avoid plication of the appendage. For example, inalternate embodiments, the clip or band is oval, rectangular or diamondin shape.

In certain embodiments, the distal end of the AA portal or the deviceused with a pericardial portal is shaped to collapse around an atrialappendage without the application of force. In these embodiments, the AAportal or the device used with a pericardial portal may comprise amechanism to open the distal end of the portal and/or the device. Forexample, and as discussed in detail below, the mechanism to open thedistal end of the portal or the device used with a pericardial portalmay comprise at least one bar or other type of mechanism to apply forcethat when urged distally, can push the distal end of the portal and/orthe device from a naturally closed configuration to an openconfiguration.

In certain embodiments, the clip and/or band is releasably engaged withthe distal end of the portal or the device used with a pericardialportal, such that when the clip and/or band is collapsed around anatrial appendage, the clip or band may be released from the end of theportal or the device so as to collapse around at least a portion of theatrial appendage.

For example, in certain embodiments, the present invention comprises adevice for tying off a left atrial appendage (LAA) or right atrialappendage (RAA), wherein the device comprises a cushioned suturematerial that may be used to tie off an atrial appendage. In anembodiment, an endoscopic loop of braded, non-absorbable suture(Ethicon, Autosuture) modified to include a strip of felt pledget toprevent injury to the base of the AA may be used. The device maycomprise a component for tightening the cushioned suture around theappendage. For example, in one embodiment, a pair of sturdy knot pushersarranged on either side of the cushioned suture may be used. In otherembodiments, and as described in more detail below, an elastic type ofband may be used to tie off the atrial appendage or exclude the atrialappendage from circulation. In other embodiments, and as described inmore detail below, a clip device may be used to tie off the atrialappendage or exclude the atrial appendage from circulation. In otherembodiments, and as described in more detail below, an elastic type ofclip device may be used to tie off the atrial appendage or exclude theatrial appendage from circulation.

In each of the devices, systems and methods of the invention, the AAportal or the device used with a pericardial portal may be configuredspecifically to access either the left atrial appendage or the rightatrial appendage.

For example, in certain embodiments, the methods of the invention maycomprise inserting an atrial appendage portal of the invention, or adevice of the invention into an outer pericardial portal and positioningthe distal opening of the atrial appendage portal or the device at thesurface of the atrium. In an embodiment, at least a portion of thedistal end of the atrial appendage portal, pericardial portal, or thedevice is curvilinear such that the distal opening is not parallel tothe longitudinal axis. Also, an endoscope may be used to provide animage of body structures present near the distal end of the portal orthe device. The method may further comprise applying suction within thelumen of the atrial appendage portal or the device used with apericardial portal to create a seal between the distal opening of theportal and/or the device and at least part of the atrial appendage.

The method may, in certain embodiments, comprise positioning one of thedevices described herein to exclude and/or remove an atrial appendage atthe distal end of the atrial appendage portal.

For example, in one embodiment, the AA portal or the device to be usedwith a pericardial portal comprises a tying band configured to be tiedaround a portion of the atrial appendage. In an embodiment, the tyingband is a suture. Or other types of tying elements, e.g., string,thread, plastic or metal wires, and the like may be used. In anembodiment, at least a portion of the suture comprises a materialdesigned to cushion the suture. In this embodiment, the method maycomprise providing the suture at the distal opening of an AA portal orthe device used with a pericardial portal, using the suture to encircleat least a portion of the atrial appendage, and tightening the suturearound the atrial appendage to exclude the atrial appendage from theatrium to which the appendage is attached.

In certain embodiments, the distal end of the atrial appendage portal orthe device used with a pericardial portal may be configured to becollapsible around an atrial appendage. Or, the distal end of the atrialappendage portal or the device used with a pericardial portal may besubstantially firm, so as to maintain an open configuration throughoutthe procedure.

In other embodiments, and as described in detail herein, the device fortying off or occluding the atrial appendage may comprise an expandableand/or contractible band and/or clip positioned on or near the distalend of the AA portal or the device used with a pericardial portal. Thus,in certain embodiments of the methods of the invention the expandableand/or contractible band is removed from the distal end of the portal orthe device used with a pericardial portal so as to encircle at least aportion of the atrial appendage to exclude the atrial appendage from theatrium to which the appendage is attached. In an embodiment, and asdescribed in more detail below, the expandable and/or contractible bandor clip is configured to close around the atrial appendage uponemplacement of the clip and/or band on the atrial appendage.

In certain embodiments, an expandable and/or contractible band or clipfor occluding or tying off the atrial appendage may be releasablysecured to the inner lumen of the atrial appendage portal or the deviceused with a pericardial portal. In certain embodiments, the expandableand/or contractible band or clip may comprise a suture to secure theexpandable and/or contractible band or clip to the inner lumen of theatrial appendage portal or the device used with a pericardial portal.

In certain embodiments, the clip and/or band is shaped to have at leasttwo longer sides and two shorter sides such that when the clip and/orband is closed around the atrial appendage, the longer sides flatten theappendage in a manner so as to substantially avoid plication of theappendage. For example, in alternate embodiments, the clip or band isoval, rectangular or diamond in shape.

In certain embodiments, the distal end of the AA portal or the deviceused with a pericardial portal is shaped to collapse around an atrialappendage without the application of force. In these embodiments, the AAportal or the device used with a pericardial portal may comprise amechanism to open the distal end of the AA portal and/or the device. Forexample, and as discussed in detail below, the mechanism to open thedistal end of the AA portal and/or the device may comprise at least onebar or other mechanism that can be used to apply force that when urgeddistally, pushes the distal end of the AA portal and/or the device froma naturally closed configuration to an open configuration.

In certain embodiments, the clip and/or band is releasably engaged withthe distal end of the AA portal or the device used with a pericardialportal, such that when the clip and/or band is collapsed around anatrial appendage, the clip or band may be released from the end of theAA portal or the device so as to collapse around at least a portion ofthe atrial appendage.

Or, the method may comprise using an inflatable member positioned on thedistal end of the AA portal or the device used with a pericardial portalto secure the band or clip on the distal end of the portal. For example,in an embodiment, an expandable and/or contractible band is positionedproximal to the inflatable member such that when the inflatable memberis inflated, the band or clip is secured on the distal end of the portalor the device used with a pericardial portal, and when the inflatablemember is deflated, the band or clip can be released from the distal endof the portal or the device used with a pericardial portal.Alternatively, the expandable and/or contractible band or clip may bepositioned substantially on top of the inflatable member, such that whenthe inflatable member is deflated, the band or clip is secured on thedistal end of the portal or the device used with a pericardial portal,and when the inflatable member is inflated, the band or clip is pushedoff of the distal end of the portal or the device used with apericardial portal.

In other embodiments, the present invention comprises systems for tyingoff an atrial appendage. For example, the system may comprise a devicefor tying off an atrial appendage, and an AA portal and/or a pericardialportal. In certain embodiments, the device used with the systemcomprises a suture configured to be tied around a portion of the atrialappendage. Also, in certain embodiments, at least a portion of thesuture comprises a material designed to cushion the suture. Or, in otherembodiments, and as described in more detail below, an elastic type ofband may be used to tie off the atrial appendage or exclude the atrialappendage from circulation. Or, in other embodiments, and as describedin more detail below, a clip may be used to tie off the atrial appendageor exclude the atrial appendage from circulation. Or, in otherembodiments, and as described in more detail below, an elastic type ofband or clip may be used to tie off the atrial appendage or exclude theatrial appendage from circulation.

As described in more detail herein, the AA portal may comprise a singleportal and/or may be used in conjunction with a second, outer cannula orportal. In certain embodiments, the system comprises an outerpericardial portal for delivering the AA portal and/or the device foroccluding the atrial appendage to an atrial appendage.

The AA portal or the device used with a pericardial portal may use anexpandable/contractible band and/or a clip for tying off the atrialappendage. The band and/or clip may be positioned on the outercircumference or the inner circumference of the distal end of the AAportal or the device used with a pericardial portal. In certainembodiments, the band/clip for occluding the AA may be releasablyattached (e.g., via a suture that can be cut) at the distal end of theAA portal or the device. Or, in certain embodiments, the AA portal orthe device may be configured such that a band and/or clip for occludingthe atrial appendage (e.g., an atrial tying band/clip) may be positionedby urging the band/clip through the inner lumen to the distal end of theAA portal and/or the pericardial portal.

The expandable/contractible band and/or clip may be, in certainembodiments, an elastic (or other expandable) circular band as describedin more detail herein. The band/clip may be, in certain embodiments, arectangular, square, circular or oval clip as described in more detailherein.

Thus, in certain embodiments, upon insertion of the atrial appendageinto the AA portal or the device used with a pericardial portal, a bandand/or clip positioned on the outer circumference of the AA portal orthe device can then be slipped off of the end of the AA portal or thedevice and onto the atrial appendage (e.g., at or near the base of theatrial appendage) so as to constrict the atrial appendage in a way suchthat most or all of the atrial appendage is functionally isolated fromthe rest of the heart. For example, an outer cylinder concentric withthe outer diameter of the device may be positioned near the distal endof the device. In an embodiment, the outer cylinder has an innerdiameter that is larger than the outer diameter of the device and/or theatrial appendage portal, but smaller than the outer diameter of theexpandable and/or contractible bands. In this way, when the outercylinder is advanced distally, it can urge the band off of the deviceand/or the atrial appendage portal and onto the atrial appendage.

In other embodiments, upon insertion of the atrial appendage into the AAportal, a tying band positioned on the inner circumference of the AAportal or the device can be slipped off of the end of the AA portal orthe device and onto the atrial appendage (e.g., at or near the base ofthe atrial appendage) so as to constrict the atrial appendage in a waysuch that most or all of the atrial appendage is functionally isolatedfrom the rest of the heart. In certain embodiments, upon insertion ofthe atrial appendage into the AA portal or the device, the band and/orclip may be urged through the inner lumen of the AA portal or the deviceand slipped onto the atrial appendage (e.g., at or near the base of theatrial appendage) so as to constrict the atrial appendage in a way suchthat most or all of the atrial appendage is functionally isolated fromthe rest of the heart.

Also, in certain embodiments, the AA portal, the pericardial portal, orthe device used with a pericardial portal may have an inflatable memberpositioned at the distal end. The inflatable member (e.g., balloon) mayin certain embodiments, minimize any trauma that can result from contactof the portal(s) and/or the device with the atrial appendage (e.g., asthe atrial appendage is engaged by the AA portal).

Additionally and/or alternatively, the inflatable member (e.g.,balloon), or a second inflatable member, may in certain embodiments,help keep an expandable and/or contractible band and/or clip on the AAportal or the device used with a pericardial portal until the bandand/or clip is ready to be positioned on the atrial appendage. Forexample, once the atrial appendage is inserted into the AA portal or thedevice, the balloon may be deflated such that the band and/or clip canbe slipped off of the distal end of the AA portal or the device and ontothe atrial appendage. For example, in an embodiment, the expandableand/or contractible band and/or clip is positioned proximal to theinflatable member such that when the inflatable member is inflated, theband and/or clip is secured on the distal end of the portal and/ordevice, and when the inflatable member is deflated, the band can bereleased from the distal end of the portal and/or device.

Additionally and/or alternatively, an inflatable member (e.g., balloon)may in certain embodiments, be used to push the expandable and/orcontractible band and/or clip off of the end of the AA portal or thedevice used with a pericardial portal and on to the atrial appendage.For example, in an embodiment, the expandable and/or contractible bandis positioned substantially on top of the inflatable member, such thatwhen the inflatable member is deflated, the band is secured on thedistal end of the portal or the device, and when the inflatable memberis inflated, the band is pushed off of the distal end of the portal orthe device.

Additionally and/or alternatively, other control release mechanisms(e.g., balloon, lever, sutures) may be used to position the expandableand/or contractible band and/or clip off of the end of the AA portal orthe device used with a pericardial portal and on to the atrialappendage. For example, in an embodiment, the expandable and/orcontractible band and/or clip is positioned within the inner lumen ofthe AA portal or the device used with a pericardial portal such thatwhen the band and/or clip is open, it is secured on the distal end ofthe portal or the device used with a pericardial portal and whenreleased, the band and/or clip closes around the atrial appendage and isreleased from the distal end of the AA portal or the device used with apericardial portal. In certain embodiments, the band/clip for tying offthe AA may be releasably attached (e.g., via a suture that can be cut)at the distal end of the AA portal or the device used with a pericardialportal for release and positioning on an AA.

Additionally and/or alternatively, the expandable and/or contractibleband and/or clip may be positioned by urging the band and/or clipthrough the lumen of the AA portal or the device and on to the atrialappendage. For example, in an embodiment, the expandable and/orcontractible band and/or clip is positioned on a separate device andurged through the inner lumen of the AA portal, pericardial portal, or adevice used with a pericardial portal, such that when the AA portal orthe pericardial portal is open, the band and/or clip is secured on thedistal end of the portal or the device, and when released, the bandand/or clip closes around the atrial appendage.

The present invention also comprises methods for using a pericardial orsubxyphoid approach to provide atrial appendage therapies. The methodmay comprise the steps of inserting a device for tying off an atrialappendage (e.g., knot pushers and suture, or an expandable and/orcontractible band and/or clip) into an AA portal or a pericardialportal, or inserting an AA portal having such a device positioned at itsdistal end into a pericardial portal.

In certain embodiments, the AA portal or pericardial portal is asubxyphoid cannula. Or, the AA portal may be used in conjunction with anouter pericardial portal. The method may then comprise using thepericardial portal or AA portal to access the pericardial sac asdescribed herein. The pericardial portal or AA portal may then bemaneuvered within the pericardial sac until the distal end of thepericardial portal or AA portal abuts the atrial appendage.

Thus, in certain embodiments, a single portal may be used. In otherembodiments, the AA portal may be used with an outer pericardial portalhaving a lumen into which the AA portal is inserted. Or in otherembodiments, a pericardial portal is used in combination with the devicefor occluding the atrial appendage.

For example, where an inner AA portal or a device used with apericardial portal is used, the AA portal or the device used with apericardial portal may be manipulated through an outer percardioscopicportal such that the distal end of the AA portal or the device used witha pericardial portal abuts the tip of the atrial appendage. Once the tipof the atrial appendage is adjacent to the distal end of the AA portalor the device used with a pericardial portal, suction may be applied tothe AA portal or the device to aspirate at least a portion of the atrialappendage into the AA portal or the device.

At this point, in certain embodiments, the expandable and/orcontractible band and/or clip may be released at the distal end of theAA portal or the device used with a pericardial portal and onto theatrial appendage. The band and/or clip can then contract around theatrial appendage so as to be snugly positioned on the atrial appendageand tie off the atrial appendage from the rest of the atrium.

In other embodiments, a cushioned suture may be manipulated through a AAportal or the pericardial portal so as to abut or almost abut the atrialappendage. Next, the cushioned suture may be positioned around theatrial appendage manually by the operator (e.g., physician), and thentightened around the atrial appendage so as to tie off the atrialappendage from the rest of the atrium.

The AA portal and/or pericardial portal may, in certain embodiments,comprise an endoscope to allow the user to visualize the distal end ofthe portal.

Also, in various embodiments, the AA portal and/or the pericardialportal and/or the device used with a pericardial portal may have acurvilinear distal portion such that the distal opening is not parallelto the proximal opening of the delivery cannula.

In some embodiments, either the percardioscopic portal or the AA portalmay comprise an inner access member (e.g., an inner cannula), whereinthe inner cannula is configured to be inserted in the percardioscopicportal and/or the AA portal. Or, multiple inner access members may beused.

Additionally, in certain embodiments, suction can be applied within thelumen of the percardioscopic portal and/or the AA portal and/or thedevice used with a pericardial portal. Also, in certain embodiments, thepericardial portal and/or the AA portal and/or the device used with apericardial portal may comprise a soft material surrounding the distalopening such that when the portal or the device used with a pericardialportal is positioned to have the distal opening abut atrial appendage,and as suction is applied within the lumen of the portal, a seal isformed between the distal opening of the portal and the atrialappendage. Additional embodiments of the portals as described herein maybe employed with the devices, systems and methods for atrial therapy.

The present invention may be understood by reference to the figures andfollowing description of example embodiments of the invention.

FIG. 1 demonstrates the insertion of an AA portal (2) or a pericardialportal in the subxyphoid position in accordance with an embodiment ofthe present invention. In an embodiment, an incision (4) is made in themidline of the epigastrium just below the xyphoid process. The incisioncan be extended through the subcutaneous fat and the midline fascia butremains outside the peritoneal cavity. The incision can then becontinued further cephalad until the pericardium is encountered. Thepericardium may then be entered sharply and a defect created largeenough to easily accept the portal. The portal can then be positionedbehind the sternum within the pericardium and directed to the LAA (6) orthe RAA on the heart (8). Visualization can be provided by an endoscope(10) inside the inner lumen of the portal.

FIG. 2 demonstrates an AA portal of the invention (2) and endoscope (10)in the inner lumen (48) of the AA portal, where the distal end of the AAportal is abutting an atrial appendage (e.g., LAA) (24). In anembodiment, a cap (12) on the proximal end of the AA portal, allows theendoscope access into the lumen (48) and provides an air tight seal tocontain suction within the lumen (48).

In one embodiment as depicted here, the central lumen (48) of an AAportal is continuous with a side port (14) which may be connected tosuction (16) via a connector (18). In one embodiment, an opening (20)for the side port (14) is connected to the central lumen (48) of the AAportal. In this way, when suction is applied to the side port (14),application of suction to the distal end (22) of the AA portal at theLAA (24) may be controlled by occlusion of the opening (20). Forexample, when the opening (20) is covered, the vacuum provided (16) isapplied to the distal end (22). As discussed in more detail herein, asimilar configuration may be used to provide suction in the inner lumenof a device used with the pericardial portal.

Also shown in FIG. 2 is an expandable AA (e.g., occlusion) band (26)located on the outer circumference of the distal end of the AA portal(2) and overlying an inflatable member (e.g., balloon) (28). In anembodiment, the balloon (28) may be inflated and deflated via a plungersyringe (30) (or a similar type device that can be used to inflate aballoon) which passes air or fluid into the balloon (28) via a lumen(32) separate from the central lumen of the AA portal. As noted herein,in certain embodiments, deflation of the balloon allows for theexpandable and/or contractible band (26) to contract such that the bandis not tightly fixed on the end of the AA portal, and can be slipped offonto the base of the LAA (24) or the RAA. For example, in someembodiments, an outer cylinder may be urged distally along the length ofthe AA portal and used to engage the band so as to push the banddistally off the end of the AA portal.

FIG. 3 illustrates the distal end of an AA Portal (2) andocclusion/exclusion of an AA (24) using an AA portal knot pusher (34)and a felt reinforced lasso-type tying band (36). Or, such a an AAportal knot pusher (34) and a felt reinforced lasso-type tying band (36)can be delivered to the atrial appendage using a pericardial portal. Or,such an AA portal knot pusher (34) and a felt reinforced lasso-typetying band (36) can be delivered to the atrial appendage using an AAportal inserted into a pericardial portal.

An endoscope (10) within the lumen of the AA portal may providevisualization of the LAA (24) within the central lumen (48) of the AAportal (and/or a pericardial portal). In one embodiment, suction may beapplied to the central lumen (48) of the AA portal (2) which encouragesthe LAA (24) into the central lumen (48) and into the felt reinforcedlasso (36) (FIG. 3A). In certain embodiments, the application of suctioncan be used to create a seal between the epicardium surrounding the LAA(38) and the distal end of the AA portal (2). Once the LAA (24) isadequately within the tying band (36), the operator may, using anaccessory device such as a cannula or other device that can access thedistal end of the lasso, manipulate the AA portal knot pusher (34) tocinch the tying band around the base of the LAA in the proper location.

FIG. 3B demonstrates the tying band (36) tight around the base of theLAA (24) after the vacuum has been released and the AA portal (2) hasbeen withdrawn from the epicardium (38). The tying band (36) may be heldsecure by the knot (40) created by the suture (42) that was within theknot pusher. Once security is verified, the remaining suture can bedivided and removed.

FIG. 4 further demonstrates one embodiment of the use of a lasso-typetying band for tying off an atrial appendage using a pericardialapproach with an AA portal or a pericardial portal. FIG. 4A shows thedistal end of a tying band comprising an endoscopic loop/loops of suture(42) reinforced with felt as a cushion (44). Or, other types of materialto cushion and reinforce the suture may be used. More than one knotpusher (34) and more than one loop of suture (42) may be used.

For example, in one embodiment, a braided suture (42) is threadedthrough an appropriately sized piece of cushioning material and tied inan adjustable manner (e.g., a slip knot or other adjustable loop) (40).In alternate embodiments, the felt may have a diameter of about 1 to 10mm, or 2 to 8 mm, or 3 to 7 mm, or 4 to 6 mm, or about 5 mm. Also, inalternate embodiments, the cushioning material may have a length ofabout 1 to 10 cm, or 2 to 8 cm, or 3 to 7 cm, or 4 to 6 cm, or about 5cm. The cushioning material may be placed around the LAA (24) (FIG. 4B)using a sturdy knot pusher or more than one knot pusher (34) (FIG. 4B).The knot pusher(s) (34) may be used to tighten the knot (40) around thebase of the LAA (24) until it is secure and excludes the LAA (24) fromthe left atrium (46) (FIG. 4C). Once secured (FIG. 4D), the suture (42)may be cut using a cutting tool that can also be delivered to the siteusing the atrial appendage portal of the present invention. The LAA canthen be safely excised using an endoscopic stapling device such as thosethat are commercially available (Ethicon, Covidian). This improveddevice as well as the AA endoscopic loop can be positioned under directendoscopic visualization using the endoscope within the paracardioscopiccannula. The felt cushion (44) and loop of the suture (42) withadjustable knot (40), in one embodiment, may be mounted inside theopening of the distal lumen (48) (FIG. 4E) so that when the knotpusher/pushers (34) are advanced, the cushion (44) and suture loop (42)are released from the cannula (2) and secured around the base of the LAA(24).

FIG. 5 further illustrates an embodiment of using a AA portal having anexpandable/contractible band at its distal end along with an endoscopepresent within the lumen. In this embodiment, a cylindrical AA Portal(2) (FIG. 5A) may be delivered to the LAA alone (FIG. 5B) or via anouter paracardioscopic cannula/portal, and used to aspirate the LAA intoa central lumen (48) (FIG. 5C). The end of the AA portal (2) may, incertain embodiments, be covered by an inflatable balloon (28) so as tobe less traumatic to the LAA. An elastic band (26) can be loaded overthis balloon, or may be positioned on the outer circumference of the AAportal, but proximal to the balloon. In this way, the balloon wheninflated will keep the band on the end of the device.

FIG. 5 panels B-C, illustrates a method of deploying an expandableand/or contractible band for isolation of the LAA according to oneembodiment of the present invention. As shown in FIG. 5B, the device maycomprise a balloon (28) positioned on the distal end of the AA Portal(2). By inflating the balloon, a band (26) that is to be used to isolatethe AA can be secured to the end of the delivery device (e.g., whereinthe band is positioned on the outside circumference of the LAA, butproximal to the balloon). The central suction lumen (48) of theinstrument may be positioned around the LAA (24) and suction applied toaspirate the LAA into the central lumen (FIG. 5C). Once the LAA (24) iswithin the AA portal (2), the balloon (28) at the distal end of the AAportal may be deflated to allow the AA band (26) to be released andpositioned on the LAA 24 (FIG. 5D). This type of delivery mechanism mayalso be used with a device that is used in conjunction with apericardial portal.

FIG. 6 demonstrates another embodiment showing the deployment of anexpandable AA occlusion band (26) at the base of the LAA (24). In thisembodiment, a balloon (28) at the distal end of an AA portal (2) may beinflated so as to push band (26) that is positioned on top of or distalto the balloon off of the distal end of the AA portal and onto the baseof the LAA. Panel 6A shows the AA portal 2 positioned with the distalend of the portal around the LAA (24). In FIG. 6A, the balloon (28) isdeflated and the band (26) is on the distal end of the AA portal (2). InFIG. 6B, the balloon (28) is inflated, thereby pushing the band (26) offof the distal end of the AA portal and onto the base of the LAA (24)where it can contract to occlude the AA. This type of delivery mechanismmay also be used with a device that is used in conjunction with apericardial portal.

In certain embodiments, the AA portal or the device that is used inconjunction with a pericardial portal may comprise a collapsible distalend with a clip and/or band that can be positioned in the distal end ofthe AA portal or the device that is used in conjunction with apericardial portal and then allowed to collapse around an atrialappendage. In this embodiment, the AA portal or the device used with apericardial portal may be positioned such that the atrial appendage isinserted into the distal end of the portal or the device, e.g., with thehelp of suction applied to the inner lumen of the AA portal or thedevice. Next, the distal end of the AA portal and associated clip and/orband may be collapsed around the atrial appendage. Once the clip and/orband is in position around the atrial appendage (so as to occlude theatrial appendage from the rest of the atrium), the clip and/or band maybe released from the AA portal or the device so as to be left on theatrial appendage when the portal is removed.

FIG. 7 demonstrates an embodiment of an AA portal or a device used witha pericardial portal having a collapsible distal end. This embodimentillustrates a rectangular portal with a mechanism for controlled releaseand deployment of a distal linear band/clip at the appendage. In oneembodiment, the central lumen (48) of the AA portal is continuous with aside port (14) which may be connected to suction (16) via a connector(18). In one embodiment, an opening (20) for the side port (14) isconnected to the central lumen (48) of the AA portal. In this way, whensuction is applied to the side port (14), application of suction to thedistal end of the AA portal (22) is controlled by occlusion of theopening (20). For example, when the opening (20) is covered, the vacuumis provided (16) to the distal end (22). The distal end of the portal(22) may be made of pliable and collapsible material (e.g., plastic,silicone and the like). In certain embodiments, the distal end of theportal may be held open by a sliding bar (50) or other similar typemechanism that can be used to apply force distally. In certainembodiments, the sliding bar may be contained within a slot (52)positioned on the side of the portal. In an embodiment, there are aplurality of slots. For example, in an embodiment, there is a slot (52)and a sliding bar (50) on two sides of the portal (back slot not visiblein FIG. 7A). Both slots (52) may contain a sliding bar (50) which may beacted upon by moving a thumb bar (54) which is connected to the slidingbar (50) by a connecting bar (56). The distal end of the sliding bar(50) may divide into two (or more) separating bars (58 a, 58 b) whichcan be separated and forced apart by a fulcrum (60). When the thumb bar(54) is advanced distally, the sliding bar (50) may advance, pushing theseparating bars (58 a, 58 b) against the fulcrum (60), thereby causingthem to separate and open the distal linear band/clip and, therefore,the distal end of the portal (22). This action can hold the distal andpliable part of the portal (22) open. Or, other mechanisms for spreading(opening) the distal end of the portal may be used. In an embodiment,the atrial appendage may then be inserted into the open distal end ofthe AA portal.

FIG. 7B illustrates a rectangular portal (2) with the distal end in theclosed position. In this embodiment, the thumb bar (54) has beenwithdrawn proximally, retracting the sliding bar (50) and allowing theseparating bars (58 a, 58 b) to come together and close the distal endof the portal (22). Also shown in FIGS. 7A and 7B is a linear clip/band(62) located at the distal end of the AA portal (2). In one embodiment,the linear band/clip may be designed with intrinsic elastic propertieswhich act to force the linear band/clip closed. As described above,moving the thumb bar (54) distally or proximally, respectively, can openand close the linear band/clip (62). The linear band/clip (62), when inposition, can be deployed and left in position at the appendage as theportal (2) is removed.

A similar configuration can be employed for a device that is used with apericardial portal. Thus, shown in FIG. 7C is such a device 33,comprising a rectangular cylindrical container that has a proximal seal35 surrounding a rod 37, or other type of access member that extendsproximally for access by a user.

FIG. 8 demonstrates an embodiment of the linear band/clip for occlusionof an atrial appendage. The linear band/clip, may in alternateembodiments have two sides (64). The sides of the clip may be fashionedfrom a solid, or a semi-solid, or a flexible material such that thesides of the clip can be closed around an atrial appendage so as toocclude the atrial appendage from the rest of the atrium (FIG. 8Aillustrates one side). FIGS. 8B-8E illustrate various views of theband/clip. FIGS. 8B-8D illustrate embodiments with the linear band/clipin the open position; FIG. 8E illustrates an embodiment with theband/clip closed. Also, FIGS. 8A-8C illustrate and embodiment whereinthe band/clip is covered with a cloth collar (68); FIGS. 8D and 8Eillustrate embodiments of the linear band/clip without the cloth collars(68).

In certain embodiments, the clip comprises solid sides (64), which havean incorporated elastic component (66) which can act as a band to exerta continuous circumferential closing force. The solid component (64)supports the linear band/clip structurally to equally distribute theclosing force on the atrial appendage. This equal distribution canprevent bunching or placation of the appendage and may effectivelyencourage the sides of the non-circular appendage into opposition.

As noted above, in certain embodiments, a cloth collar(s) (68) may beattached to the linear band/clip provide rotational stability. Also, incertain embodiments, the cloth collar may be used to secure theband/clip to the distal end (22) (e.g., the inner circumference) of theportal (2). Thus, in certain embodiments, deployment of the clip and/orband around an atrial appendage may occur by removing a securing suturefrom the collar (68), thereby releasing the linear band/clip (62) fromthe portal (2).

In alternate embodiments, the elastic band and/or clip may have adiameter of about 1 to 5 cm, or 2 to 4 cm, about 3 cm. Also, inalternate embodiments, the solid clip component may have a length ofabout 1 to 10 cm, or 2 to 8 cm, or 3 to 7 cm, or 4 to 6 cm, or about 5cm.

FIG. 9 demonstrates an embodiment of an oval AA portal comprising aflexible and/or collapsible distal end. In an embodiment, the distal endis oval; in this way, when the end of the portal is collapsed around theatrial appendage, the longer sides of the opening may flatten the AAwhile minimizing plication of the appendage. Or, in some cases, thedistal end may be circular. Again, in certain embodiments (as describedabove but not shown in FIG. 9), the central lumen of the AA portal maybe continuous with a side port which is connected to suction via aconnector. In this way, when suction is applied to the side port,application of suction to the distal end of the AA portal can becontrolled by occlusion of the opening to the side port. For example,when the opening to the side port is covered, the vacuum provided isapplied to the distal end of the AA portal allowing for the AA portal tobe securely positioned around an atrial appendage.

In certain embodiments, and as illustrated in FIG. 9A, the distal end(22) of the portal may be made of a pliable and collapsible material(e.g., plastic, silicone or the like). In certain embodiments, thedistal end of the portal may be held open by a sliding bar (50). Incertain embodiments, the sliding bar may be contained within a slot (52)positioned on the side of the portal. In an embodiments, there are aplurality of slots. For example, in an embodiment, there is a slot (52)and a sliding bar (50) on two sides of the portal (back slot not visiblein FIG. 9A). As with the rectangular AA portal, both slots (52) maycontain a sliding bar (50) which can be acted upon (i.e., urged distallyand/or proximally) by moving a thumb bar (54) which is connected to asliding bar (50) by a connecting bar (56). The distal end of the slidingbar (50) may divide into two (or more) separating bars (58 a, 58 b)which can be separated and forced apart by a fulcrum (60). When thethumb bar (54) is advanced distally, the sliding bar (50) may beadvanced, pushing the separating bars (58 a, 58 b) against the fulcrum(60), thereby causing the bars (58 a, 58 b) to separate from each otherand open the distal band/clip and, therefore, the distal end of theportal (22). This action can then hold the distal and pliable part ofthe portal (22) open. Or, other mechanisms for spreading (opening) thedistal end of the portal may be used. In an embodiment, the atrialappendage may then be inserted into the open distal end of the AAportal.

FIG. 9B illustrates an oval portal (2) with the distal end in the closedposition. In this configuration, the thumb bar (54) has been withdrawnproximally, retracting the sliding bar (50) and allowing the separatingbars (58 a, 58 b) to come together and close the distal end of theportal (22). Also shown in FIGS. 9A and 9B is an oval clip/band (70)located at the distal end of the AA portal (2). In one embodimentdepicted here, the oval band/clip is designed with intrinsic elasticproperties which act to force the oval band/clip closed. The action atthe thumb bar (54) opens and closes the oval band/clip (70). The ovalband/clip (70), when in position, can be deployed and left in positionat the appendage as the portal (2) is removed.

A similar configuration can be employed for a device that is used with apericardial portal. Thus, shown in FIG. 9C is such a device 33,comprising an oval cylindrical container that has a proximal seal 35surrounding a rod 37, or other type of access member that extendsproximally for access by a user.

FIGS. 10A-10E demonstrates embodiments of an oval band/clip forocclusion of an appendage. The sides (72) of the clip may be fashionedfrom a solid, or a semi-solid, or a flexible material such that thesides of the clip can be closed around an atrial appendage so as toocclude the atrial appendage from the rest of the atrium FIGS. 10A-10Eillustrate various views of the oval band/clip. FIGS. 10A-10D illustrateembodiments with the oval band/clip in the open position; FIG. 10Eillustrates an embodiment with the oval band/clip closed. FIG. 10Dillustrates and embodiment of the oval band/clip with the cloth collars(68).

In certain embodiments of the oval/circular clip, the solid sides (72)may have an incorporated elastic component (74) which acts as a band toexert a continuous circumferential closing force. The solid component(72) can support the oval band/clip structurally to equally distributethe closing force on the appendage. This equal distribution may preventbunching or placation of the appendage and effectively encourages thesides of the non-circular appendage into opposition.

As noted with the rectangular clip, cloth collars (68) may be attachedto the oval and/or circular band/clip provide rotational stability andto secure the band/clip to the distal end (22) of the portal (2).

Thus, in certain embodiments, deployment may occur by removing asecuring suture from the collar (68), thereby releasing the ovalband/clip (70) from the portal (2). In alternate embodiments, theelastic band component may have a diameter of about 1 to 5 cm, or 2 to 4cm, about 3 cm. Also, in alternate embodiments, the solid clip componentmay have a length of about 1 to 10 cm, or 2 to 8 cm, or 3 to 7 cm, or 4to 6 cm, or about 5 cm.

As noted herein, the clip or expandable elastic component may beselected from a variety of shapes. In certain embodiments, the clipand/or band is shaped to have at least two longer sides and two shortersides such that when the clip and/or band is closed around the atrialappendage, the longer sides flatten the appendage in a manner so as tosubstantially avoid plication of the appendage. For example, clips thatare oval, rectangular, diamond-shaped or the like may be used.

FIG. 11, panels A-D, illustrates clips positioned around an atrialappendage in accordance with various embodiments of the invention. Thus,FIGS. 11A and 11B show an oval distal band/clip having an elasticcomponent (74) and flexible sides (72) positioned around an atrialappendage (24) emanating from the atrial surface (46) where FIG. 11Ashows the clip open, and FIG. 11B shows the clip closed around theatrial appendage. FIGS. 11C and 11D shows a diamond-shaped clip havingan elastic component (74) and flexible sides (72) positioned around anatrial appendage (24) emanating from the atrial surface (46) where FIG.11C shows the clip open, and FIG. 11D shows the clip closed around theatrial appendage.

All publications and patent applications cited herein are incorporatedby reference in their entireties. This application incorporates byreference herein in their entireties U.S. patent application Ser. No.12/642,137, entitled “Methods and Devices for Endoscopic Access to theHeart” and filed Dec. 18, 2009, U.S. patent application Ser. No.12/456,855 entitled “Endoscopic Cardiac and Thoracic Surgical Devicesand Systems and Methods of Use of Such Devices and Systems” filed onJun. 23, 2009, U.S. Provisional Patent Application 61/135,260, filed onJul. 19, 2008, and entitled “Totally Endoscopic Cardiac and ThoracicSurgical Devices and Methods,” and U.S. Provisional Patent Application61/191,062, filed on Sep. 6, 2008, entitled “Pericardial andExtrapericardial Surgical Devices and Methods.”

What is claimed is:
 1. A device for performing a surgical procedure onan atrial appendage via a pericardial approach, wherein at least aportion of the device is configured for insertion of at least a portionof the atrial appendage into a portion of the device and configured toexclude and/or remove an atrial appendage from an atrium to which theappendage is attached.